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| Name | Class |
|---|---|
| SCRI Development Innovations, LLC | OTHER |
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This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with select relapsed or refractory solid tumors.
TGR-1202 will be evaluated alone or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with adenocarcinoma of the pancreas, adenocarcinoma of the colon, rectum, gastric and GE junction cancer, and GI Stromal Tumor (GIST) who have relapsed from or are refractory to prior treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TGR-1202 | Experimental | TGR-1202 daily dose |
|
| TGR-1202 + nab-paclitaxel + gemcitabine | Experimental | TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion |
|
| TGR-1202 + FOLFOX | Experimental | TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) |
|
| TGR-1202 + FOLFOX + Bevacizumab | Experimental | TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) + bevacizumab IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TGR-1202 | Drug | TGR-1202 oral daily dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events as a measure of safety and tolerability of TGR-1202 as a single agent and in combination in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab. | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities. | Up to 28 days after the last patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall response rate with TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab. | Up to 1 year |
| Duration of Response |
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Inclusion Criteria:
Histologically confirmed:
Relapsed or refractory disease
Measurable lesion by RECIST 1.1
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johanna Bendell, MD | Sarah Cannon Research Instititue (SCRI) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Trial Site | Nashville | Tennessee | 37203 | United States |
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| nab-paclitaxel + gemcitabine | Drug | IV infusion |
|
|
| Oxaliplatin + Folinic acid + Fluorouracil | Drug | IV infusion |
|
|
| Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab | Drug | IV Infusion |
|
|
Duration of response with TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
| Up to 1 year |
| Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax). | This endpoint will measure the plasma PK profile of TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab. | At selected timepoints up through 6 months |
| Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax). | At selected timepoints up through 6 months |
| Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC) | At selected timepoints up through 6 months |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000626319 | umbralisib |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| D000068196 | Albumin-Bound Paclitaxel |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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